Endotrachael tube with suction catheter and system

ABSTRACT

An endotracheal tube and suction catheter system having an inflatable cuff with a unique shape, collection pocket formed by the inflatable cuff and a unique railing system for controllably guiding a suction catheter along the tube and into or proximal to the pocket. The cuff and pocket facilitate the collection of pooled secretions that accumulate in the trachea area. Pooled secretions are collected in the cuff pocket and the cuff may be pitched toward the pocket or have a concave hemispherical design at the posterior pocket end and, or a convex hemispherical design at the anterior end to further urge pooled secretions into the pocket. The cuff preferably has an elongated parallelogram-like shape to counter the rocking phenomenon caused by a patient coughing or turning. The parallelogram-like shape causes the cuff to maintain its contact with the trachea walls so secretions and fluid do not leak past the cuff balloon. The suction catheter, which is guided along the tube toward the pocket, is used to aspirate the collected secretions in the pocket and above the cuff. The railing system allows the suction catheter to be replaced without having to remove the endotracheal tube. Although the instant invention is primarily described with reference to flexible endotracheal tubes, it may also be adapted for trachea tubes, which are typically shorter and more rigid. The instant invention may also comprise a system having a suction catheter with a temperature probe and, or sublingual system probe.

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of provisional applicationSer. No. 60/445,629 filed Feb. 7, 2003.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0002] N/A

COPYRIGHT NOTICE

[0003] A portion of the disclosure of this patent document containsmaterial that is subject to copyright protection. The copyright ownerhas no objection to the facsimile reproduction by anyone of the patentdocument or patent disclosure as it appears in the Patent and TrademarkOffice patent file or records, but otherwise reserves all copyrightsrights whatsoever.

BACKGROUND OF THE INVENTION

[0004] 1. Field of the Invention

[0005] This invention generally relates to an endotracheal tube, andmore particularly, to an endotracheal tube having an inflatable cuffthat forms a tapered collection pocket when inflated for urging thecollection of secretions and a rail system adapted for securely andsafely guiding a suction catheter along the tube for facilitating theaspiration of secretions pooled in the cuff pocket and the area abovethe trachea.

[0006] 2. Description of Related Art

[0007] A well known problem with endotracheal tubes is the buildup ofexcessive oropharyngeal and gastroesophageal secretions above the cuffof the tube in the trachea and subglottic area when a patient isintubated. Endotracheal intubation is used for mechanically ventilatinga patient's lungs when the patient cannot breathe normally and/or forintroducing anesthetic gases into the lungs. However, the intubatedpatient is almost always placed at risk by the accumulation of pooledsecretions between the inflated cuff and oral pharyngeal area. Theaccumulation and stagnation of oral secretions breeds infectiousorganisms that can result in pneumonia. The accumulated secretionseventually leak into the patient's lungs or find their way into thelungs when the endotracheal cuff is deflated for removal or when apatient is turned and, or coughs. Conventional procedures for preventingpneumonia associated with tracheal intubation require confirmation thatsecretions are cleared from above the tube cuff before deflating thecuff and removing the tube. Some endotracheal tubes have a dorsal lumenformed in the walls of the tube above the cuff for draining accumulatedsecretions by suction. However, there are no known recommendations forroutinely and effectively using an endotracheal tube with a dorsallumen. This is in part due to the fact that the dorsal lumen can becomeeasily occluded, which would require complete removal of the tube. Thus,intubated patients are always at risk of developing bronchitis,pneumonia and other life-threatening infections because of pooledsecretions entering the trachea and lungs.

[0008] Up until 1936, pneumonia was the leading cause of death in theUnited States. Even with all the modern advances in medical technologyand antibiotic therapy, pneumonia is currently the sixth leading causeof death in the U.S. (CDC, 1997). Nosocomial (hospital-acquired)pneumonia is a frequent complication in mechanically-assisted ventilatorpatients, according to a national, multi-million dollar, multi-centerresearch study by the Centers for Disease Control (1997), pneumonia isthe second most common nosocomial infection in the United States and isassociated with substantial morbidity and mortality. The CDC furtherstates that because intubation and mechanical ventilation alterfirst-line patient defenses, they greatly increase the risk fornosocomial bacterial pneumonia. The risk for pneumonia is increased bythe direct access of bacteria to the lower respiratory tract, whichoften occurs because of leakage around the endotracheal cuff, thusenabling pooled secretions above the cuff to enter the trachea.According to Marino (1998), the aspiration of mouth secretions into theupper airways is the inciting event in most cases of pneumonia. Anaverage of 1 billion bacteria are found in each milliliter of saliva, soaspirating only a micro-liters of saliva can introduce large numbers ofbacteria into the airways.

[0009] According to Lewis et al (1997), endotracheal intubationinterferes with the normal cough reflex and the mucociliary escalatormechanism. Decreased consciousness depresses the cough and epiglottalreflexes, which may allow aspiration of oropharyngeal contents into thelungs. It also bypasses the upper airways in which filtration andhumidification of air normally take place (622).

[0010] Nosocomial pneumonia is a complication that not only increasesmortality/morbidity rates, but also causes substantial increases infinancial costs due to significant increases in length of stays (LOS) inhigh tech, intensive-care units. A one-two week increase in a patient'sLOS in an ICU is a very significant fiscal consideration and hardship,which can cost $3,500.00 to $5,000.00 a day.

[0011] Conventional endotracheal tubes contribute to the problemsassociated with pooled secretions in the trachea area. The conventionalendotracheal tube has an inflatable cuff that blocks the passageway andallows secretions to accumulate above the cuff. The tube has aninflation lumen that extends between a proximal end and a distal end forinflating the cuff. The inflatable cuff is joined to the tube above thedistal end to prevent the passage of fluids and gases to and from thelungs when inflated. The cuff is inflated so that it engages the tracheawall thereby providing a proper seal. However, as the trachea is sealed,oral secretions tend to pool or build up above the cuff. If thesesecretions could be safely and conveniently aspirated the foregoinghealth concerns could be eliminated or greatly reduced. However, costsand practical constraints have prevented the adoption of a reliable,cost effective endotracheal and aspiration system.

[0012] In addition to the foregoing, conventional endotracheal tubes arelimited in their use, difficult to monitor and provide methods oftreatment but no information. As endotracheal tubes invade the body, itwould be beneficial and helpful if it could provide useful information.For instance, if an endotracheal tube could be designed to also monitora patient's temperature it would provide important medical informationto a practitioner.

[0013] Moreover, an endotracheal tube that was able to provide a meansfor early detection of tissue hypoperfusion, such as structure formeasuring oropharyngeal PCO₂, would provide an additional benefit overconventional tubes. An eleveation in oropharyngeal PCO₂ is an earlywarning signal for tissue hypofusion. Limiting the risk of organ damageresulting from tissue hypoxia is one of the biggest challenges inpatient care. Because tissue perfusion and oxygenation help maintainorgan vitality, tissue perfusion is literally a matter of life anddeath. A noninvasive sublingual system known in the prior art and soldunder the trademark CapnoProbe measures PCO₂ through fiber optictechnology. Such devices comprise additional required equipment and canbe expensive. An endotracheal tube having structure for continuouslymeasuring oropharyngeal PCO₂ could provide a more economical device andmore convenient option that facilitates taking continuous measurementsand would be well received.

[0014] Endotracheal tubes are not new in the art and several haveprovided structure for draining fluid from the lungs and/or insufflatingthe lungs with oxygen or other gases. Other known devices have addressedthe problem of removing pooled secretions from the upper tracheal area,but have failed to solve the problem as contemplated by the instantinvention. Many of the endotracheal tubes known have a suction lumenthat is integrally formed along or through the wall of the endotrachealtube. This design increases the thickness of the tube and calls for theentire endotracheal tube to be discarded when the suction lumen becomesdamaged or permanently occluded or is the wrong size for the requiredaspiration. Designs that have a separate but permanently attachedcatheter can rupture the trachea wall. These endotracheal tubes andsimilar designs have edges that could scrape and cause trauma to thetracheal passageway.

[0015] The prior art devices known are disclosed in the followingpatents. U.S. Pat. No. 5,143,062, issued to Peckham, discloses anendotracheal tube comprising a double lumen through which air may becirculated, creating an indirect gentle suction through a suction eyecommunicating with the distal ends of the lumens, and located at aposition proximal to the inflation cuff. This design, however, does notprovide adequate suction necessary for aspirating secretions and iseasily occluded. The Peckham device, is not practical for convenienthospital use and appears to be unsuitably thick. U.S. Pat. No.4,305,392, issued to Chester, discloses an inflatable cuff typeendotracheal tube having a suction chamber adjacent to the upper-side ofthe cuff. U.S. Pat. No. 4,334,534, issued to Ozaki, discloses anemergency airway tube for use in resuscitation of non-breathing patientsby inserting the tube through the mouth until it randomly lodges eitherin the trachea or the esophagus. U.S. Pat. No. 4,584,998, issued toMcGrail, discloses an endotracheal tube including up to three lumens, inaddition to the primary lumen, which serves various functions to provideversatility in the treatment of patients. One lumen is used forinflating the cuff once the tube has been placed in the trachea; anotheris used to deliver oxygen or other gases by constant insufflation,intermittent jet ventilation or high frequency ventilation; and thethird is used for monitoring and irrigation. U.S. Pat. No. 4,607,635,issued to Heyden, discloses an endotracheal tube with an elongatedpassage along its length. The tube has a plurality of ports along thepassage to provide for removal of secretions that accumulate outside thetube and between the tube. U.S. Pat. No. 4,632,108, issued to Geil,discloses a flexible tubular assembly having a lumen for removing smokegenerated during lazer surgery. U.S. Pat. No. 4,637,389, issued toHeyden, discloses a tracheal tube providing an expansible channel alongits length, which normally maintains a generally concealed attitudewithin the trachael tube wall and adapts by expansion for the insertionof a suction catheter. U.S. Pat. No. 4,688,568, issued to Frass,discloses a tube that has an airway for sole esophageal obturator orendotracheal and esophageal-obturator ventilation and an inflatable cuffin the area of the tip of the airway and air-outlets in the area of thepharynx. U.S. Pat. No. 4,762,125, issued to Leiman, discloses aballoon-tipped suction catheter that embodies an elongated tube with acannula extending along the elongated tube. U.S. Pat. No. 4,840,173,issued to Porter, III, discloses an endotracheal tube having dualpassages provided by the merging of a ventilation tube and a suctiontube. U.S. Pat. No. 5,520,175, issued to Fry, discloses an endotrachealtube with an inflatable cuff having a convex shaped superior surfaceforming a collection basin to facilitate accurate suctioning while tubeis in position.

[0016] The above noted patent references fail to adequately address manyimportant issues. Conventional endotracheal and tracheal tubes lack theability to suction both oropharyngeal and gastroesophageal secretions,even when a patient is turned according to nationally instituteddecubitus prevention protocols. They fail to provide a suction catheteror lumen that is replaceable while a patient is intubated. The prior artendotracheal tube designs do not adequately accommodate chlorhexidinerinses to prevent colonization of bacteria around the trachea area abovethe cuff and can trigger cough reflexes, which allow secretions andfluids to flow past the cuff. Conventional designs also fail to countertorquing of the cuff balloon that can occur when a patient coughs.

[0017] The patent references found fail to provide an endotracheal tubethat adequately addresses the foregoing issues or that has a suctioncatheter or lumen that is replaceable while a patient is intubated,adapts to the contours of the tube and contains secretions even when apatient is turned. As the background devices fail to disclose anendotracheal tube and suction catheter system having these structuralcharacteristics, the need for such a device is apparent. The instantinvention addresses this by providing an endotracheal tube and suctioncatheter system comprising a replaceable suction/aspiration catheter,guide rail system and collection pocket that is designed to holdsecretions even when a patient is turned.

BRIEF SUMMARY OF THE INVENTION

[0018] In light of the foregoing, it is an object of the presentinvention to provide an endotracheal tube that facilitates theconvenient, safe removal of pooled secretions in the tracheal area abovethe cuff.

[0019] It is another object of the instant invention to provide anendotracheal tube having an aspiration or suction catheter that isreplaceable, smooth and adapted for traversing an endotracheal tube forroutine use of the suction catheter.

[0020] It is an additional object of the instant invention to provide anendotracheal tube system having a suction catheter that can be replacedwhile a patient is intubated with the endotracheal tube allowing forroutine suction catheter changes.

[0021] It is a further object of the instant invention to provide anendotracheal tube and suction catheter system that facilitates theintroduction of anti-microbial solutions into the tracheal area to killbacterial colonizations.

[0022] It is also an object of the instant invention to provide anendotracheal tube and suction catheter system that can decrease theoccurrence of aspiration/nosocomial pneumonia.

[0023] It is another object of the instant invention to provide anendotracheal tube and suction catheter system that can decrease therequirement for antibiotics.

[0024] It is still another object of the instant invention to provide anendotracheal tube and suction catheter system that can suction bothoropharyngeal and gastroesophageal secretions, even when a patient isturned.

[0025] It is still an additional object of the instant invention toprovide an endotracheal tube and suction catheter system thatfacilitates the use of chlorhexidine rinses to prevent colonization ofbacteria around the trachea and cuff mating surfaces in a manner thatalleviates aspiration secondary to the suction of fluids at the tracheacuff and avoids the triggering of the cough reflex as fluids migrate tothe tracheal cuff.

[0026] It is still another object of the instant invention to provide anendotracheal tube and suction catheter system having a geometric designthat counters the torque forces on the cuff when a patient coughs tokeep the walls of the cuff against the trachea wall to preventsubglottic secretions from slipping past the cuff.

[0027] It is still a further object of the instant invention to providean endotracheal tube and suction catheter system having a cuff withelongated sides to provide a greater surface area and less pressure perunit area on sensitive, delegate tracheal tissue to decrease theincidence of injuries associated with cuff pressure on the trachea.

[0028] It is yet another object of the instant invention to provide anendotracheal tube that is cost effective and adapted for existingmanufacturing techniques.

[0029] In light of these and other objects, the instant inventioncomprises an endotracheal tube and suction catheter system having aninflatable cuff with a unique shape, collection pocket formed by theinflatable cuff and a unique railing system for controllably guiding asuction catheter along the tube and into or proximal to the pocket. Thecuff and pocket facilitate the collection of pooled secretions thataccumulate in the trachea area. Pooled secretions are collected in thecuff pocket and the cuff may be pitched toward the pocket or have aconcave hemispherical design at the posterior pocket end and, or aconvex hemispherical design at the anterior end to further urge pooledsecretions into the pocket. The cuff preferably has an elongatedparallelogram-like shape to counter the rocking phenomenon caused by apatient coughing or turning. The parallelogram-like shape causes thecuff to maintain its contact with the trachea walls so secretions andfluid do not leak past the cuff balloon. The suction catheter, which isguided along the tube toward the pocket, is used to aspirate thecollected secretions in the pocket and above the cuff. The railingsystem allows the suction catheter to be replaced without having toremove the endotracheal tube. Although the instant invention isprimarily described with reference to flexible endotracheal tubes, itmay also be adapted for tracheal tubes, which are typically shorter andmore rigid. The instant invention may also comprise a system having asuction catheter with a temperature probe and, or oropharyngeal systemprobe.

[0030] The endotracheal tube generally comprises a main lumen, cufflumen, inflatable cuff with a tapered pocket and rail system designedfor guiding a suction catheter along the main lumen. The rail system isfound on the main lumen and suction catheter such that the catheterengages and slides along the main lumen to allow for the removal ofpooled secretions. The rail system comprises a monorail that traversesthe exterior surface of the main lumen and terminates at a predetermineddistance above the cuff and pocket, and a corresponding bi-railtraversing the suction catheter. The suction catheter bi-rail slidablyinterlocks with the monorail and terminates at a stop defined by thedistal end of the monorail. The monorail stop prevents the catheter fromextending too far into the trachea and cuff pocket to protect thepatient from trauma and the cuff from being punctured and to facilitateoptimum placement of the suction catheter. The monorail stop is smoothand curved and tapers downward to the tube to prevent trauma to thepatient's trachea during intubation. The bi-rail comprises twosubstantially parallel rails having a hooked contour along its interiorsurface that forms a channel for sliding over the monorail. The monorailcomprises an elongated tongue having a cross-sectional shape, such as amushroom-like shape or similar shape, that corresponds to thecross-sectional shape of the bi-rail groove. The bi-rail and tubeprovide walls of adherence for hardened, ossified secretions thatinevitably develop during long term intubation. When removing thesuction catheter the hardened secretions along the endotracheal tube,bi-rail, and in some instances the monorail, are removed. The bi-railchannel accommodates the application of a water-based lubricant, such asthose sold under the trademark Surgilube, for decreasing friction as thecatheter bi-rail is urged over the monorail. The bi-rail also providesincreased stability for inserting the suction catheter. In analternative embodiment, the cuff pocket and/or catheter section maycomprise a radio opaque material or plastic that is detectable andviewable when inserted.

[0031] The cuff balloon comprises a cuff pocket for collecting pooledsecretions. The cuff preferably has two interior pocket walls that forma tapered pocket when the cuff is inflated. The pocket walls may have ahigher tensile strength to prevent the pocket from collapsing and toachieve the desired pocket shape. The superior anterior portion of thecuff may also extend outward at or near the top end in a manner thatpitches toward the pocket or provides a hemispherical convex contourthat facilitates migration of secretions into the tapered pocket. Thecuff's posterior pocket end may also be pitched toward the pocket orhave a concave, hemispherical design to further urge secretions into thepocket. The pocket preferably expands ninety to one-hundred and eightydegrees over the tube at its widest section and tapers into a point atthe back of the pocket and a point at the top of the pocket. The pointat the top of the pocket is preferably secured to the interior wall ofthe cuff and the point at the back of the pocket is secured to the tubeproximal the bottom of the cuff. The pocket walls share common edgesbetween the two points and each have a lower edge that is secured tomain lumen. The lower edges are preferably ninety to one hundred andeighty degrees apart near the top of the pocket to achieve the properwidth of the pocket. This retains collected secretions in the pocket andcontinues to facilitate the collection of secretions when the patient isturned. The pocket walls and cuff define an airtight interior volumethat is inflated through the cuff lumen. The cuff lumen extends throughthe wall of the main tube and communicates with the inflatable cuff forselectively inflating and deflating the cuff with an external source ofair, as is known in the art. When the cuff lumen is inflated it raisesthe top point and pocket walls until fully erect. When the cuff isdeflated, the pocket collapses with the cuff. The design of the cuff andcollection pocket urges the migration of secretions into the pocket,which retains the secretions even when a patient is turned. The cuffballoon may also be impregnated or coated with an anti-microbialsolution that prevents the colonization of bacteria

[0032] The main lumen comprises the main body of the invention. The mainlumen is inserted into a patient's trachea for ventilation and/oranesthetic treatment of the patient's lungs. The cuff inflation lumenfluidly communicates with the cuff balloon for inflating and deflatingthe cuff.

[0033] To use the instant invention, a patient is intubated with theendotacheal tube. The tube may be fitted with the suction catheter atthe time of intubation or thereafter. To mount the suction catheter onthe tube, the bi-rail is aligned with and slidably inserted over themonorail so that the bi-rail wraps around the monorail. The suctioncatheter is urged down the tube until the bi-rail engages the monorailstop. When fully inserted, the suction catheter extends beyond the stopand into the cuff pocket. The same procedure is followed to insert asuction catheter while the patient is intubated. The suction cathetermay be replaced without removing the endotracheal tube by sliding thesuction catheter off the monorail and out of the patient's mouth andinserting a new catheter over the monorail as discussed. Once installed,an external vacuum source is used to aspirate secretions through thesuction catheter.

[0034] In an alternative embodiment, the instant invention may comprisea tracheostomy tube instead of an endotracheal tube. The tracheostomytube is merely a shorter, rigid version of the endotracheal tube of theinstant invention and is inserted through the neck instead of throughthe mouth. Accordingly, the tracheostomy tube of the instant inventioncomprises all the elements of the endotracheal tube.

[0035] In accordance with these and other objects, which will becomeapparent hereinafter, the instant invention will now be described withparticular reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0036]FIG. 1 is a front elevational view of the preferred embodiment ofthe endotracheal tube and suction catheter system of the instantinvention illustrating the cuff deflated.

[0037]FIG. 2 is a front elevational view of the preferred embodiment ofthe endotracheal tube and suction catheter system of the instantinvention illustrating the cuff inflated.

[0038]FIG. 3 is a front perspective partial enlarged view of thepreferred embodiment of the endotracheal tube and suction cathetersystem of the instant invention illustrating the suction catheterinstalled and the monorail stop.

[0039]FIG. 4 is a front perspective partial and exploded view of thepreferred embodiment of the endotracheal tube and suction cathetersystem of the instant invention illustrating the suction catheter priorto installation.

[0040]FIG. 5 is a cross sectional view of the preferred embodiment ofthe endotracheal tube and suction catheter system of the instantinvention taken along cross section lines 5-5 of FIG. 2.

[0041]FIG. 6 is a cross sectional view of the preferred embodiment ofthe endotracheal tube and suction catheter system of the instantinvention taken along cross section lines 6-6 of FIG. 2.

[0042]FIG. 7 is a cross sectional view of the preferred embodiment ofthe endotracheal tube and suction catheter system of the instantinvention taken along cross section lines 7-7 of FIG. 2.

[0043]FIG. 8 is a cross sectional view of the preferred embodiment ofthe rail system and catheter of the instant invention.

[0044]FIG. 9 is an illustration of the alternative embodiment of theendotracheal tube and suction catheter system of the instant inventionin use.

[0045]FIG. 10 is a cross sectional view of an preferred embodiment ofthe endotracheal tube and suction catheter system of the instantinvention taken along cross section lines 6-6 of FIG. 2.

[0046]FIG. 11 is a perspective view of an alternative embodiment of theinstant invention designed as a trachea tube.

DETAILED DESCRIPTION OF THE INVENTION

[0047] With reference to the drawings, FIGS. 1-11 depict the preferredand alternative embodiments of the instant invention, which is generallyreferenced by numeric character 10 and, or as an endotracheal tube andsuction catheter system 10.

[0048] With reference to FIGS. 1-5, the endotracheal tube and suctioncatheter system 10 generally comprises a main lumen 12 having aninflatable balloon cuff 14 with a collection pocket 30 for holdingpooled secretions, suction catheter 23 for removing the pooledsecretions and rail system 20 for guiding and positioning the suctioncatheter 23 in the vicinity of the collection pocket 30. The main lumen12 comprises a conventional endotracheal tube having a centralpassageway 16, modified balloon cuff 14, inflation lumen 17 and Murphyeyelet 18. The inflatable cuff 14 is secured to the main lumen 12, as isknown in the art, and defines the collection pocket 30 as shown in FIGS.2-5. The balloon cuff 14 is preferably shaped substantially like aparallelogram to counteract torquing of the cuff 14 when the patientcoughs. The torque force caused by coughing can cause the balloon cuff14 to release away from trachea walls allowing the passage pneumoniacausing secretions. Accordingly, one corner is raised higher than theother on at least one end and preferably on both ends. With reference toFIGS. 5 and 9, the extended, oblong anterior end 99 of the cuff 14 ispreferably convex and faces the anterior or chest of the patient whilethe oblong corner on the posterior half of the cuff is preferablyconcave and faces the posterior of the patient. The other corner at thetop end of the cuff 14 may also extend outward such that they form ahemispherical, concave surface while maintaining an overallparallelogram shape, as shown in FIG. 2. The shape of the cuff 14 at thetop end urges the flow of secretions toward and into the cuff pocket 30by utilizing gravity. The shape of the balloon cuff 14 also blocks thepassage of secretions past the cuff 14. Conventional balloon cuffs canrelease away from the trachea walls when the patient coughs allowingpooled subglotic secretions to flow past the protective cuff shieldincreasing the risk of pneumonia. The parallelogram shaped cuff 14 ofthe instant invention provides greater surface area and is shaped in amanner that keeps the cuff 14 in contact with the tracheal walls evenwhen a patient coughs. This prevents secretions from making it past theballoon cuff 14. The balloon cuff 14 also defines the collection pocketat a location in alignment with the suction end of the railing system 20to insure proper positioning of the suction catheter 23.

[0049] The balloon cuff 14 defines the collection pocket 30, whichreceives pooled secretions. With reference to FIGS. 6, 7 and 10, thecuff pocket 30 preferably comprises a first pocket wall 31 and secondpocket wall 33 secured inside the cuff volume. The pocket walls 31, 33and cuff 14 form an airtight interior volume that is inflated throughthe cuff lumen 17. The first and second walls 31, 33 each have a loweredge 34, 36, respectively, that are secured to the exterior surface ofthe main lumen 12 within the pocket 30. The first and second walls 31,33 have or share a common edge 32, which defines a top or forwardconnection point 42 and a rear connection point 44. The top connectionpoint 42 is securely attached to or formed integrally with the interiorsurface of the balloon cuff 14 proximal the top, forward pocket edge 38.The rear connection point 44 is preferably secured to the main lumen 12toward the back of the cuff 14. The first and second lower edges 34, 36,extend from the rear connection point 44 toward the forward pocket edge38 preferably at a ninety-degree angle with respect to each other. Atits widest point, the first and second lower edges 34, 36 are ninety toone hundred and eighty degrees apart. Accordingly, the lower edges 34,36 form a triangle on the upper surface of the main lumen 12 at an anglethat facilitates the collection of secretions even when a patient isturned. As the forward point 42 is attached to the cuff 14 and the rearpoint 44 is secured to the main lumen 12, the collection pocket 30 isformed when the cuff 14 is inflated. That is, the cuff 14 pulls theforward point 42 of the walls 31, 33 upward as the cuff 14 is inflatedto form the pocket 30. The pocket walls 31, 33 may have a higher tensilestrength to prevent the pocket 30 from collapsing under pressure wheninflated and to achieve the desired pocket shape.

[0050] In an alternative embodiment, the pocket 30 may include first andsecond lower barriers 35, 37, which are joined to opposite sides of themain lumen 12 at one end, respectively, and to the walls 31, 33 at theother end, as shown in FIG. 10. Alternatively, the lower barriers 35, 37may be attached to the interior of the balloon cuff 14, such that theyextend between the main lumen 12 and cuff 14, as illustrated by thephantom lines in FIG. 10. The overall size and width of the collectionpocket 30 is expanded by utilizing the lower barriers 35, 37 andexpanded further by attaching the barriers 35, 37 to the cuff lining.

[0051] The cuff lumen 17 extends through the wall of the main tube 12and communicates with the inflatable cuff 14 for selectively inflatingand deflating the cuff 14 with an external source of air pressure, as isknown in the art. When the cuff 14 is inflated it raises the top point42 and pocket walls 31, 33 until the balloon cuff 14 is fully erect.When the cuff 14 is deflated, the pocket 30 collapses with the cuff 14.The design of the cuff 14 and collection pocket 30 urges the migrationof secretions into the pocket 30, which retains the secretions even whena patient is turned.

[0052] The instant invention further comprises a suction catheter 23adapted for traversing the main lumen 12 and aspirating or suctioningsecretions from the collection pocket 30. The suction catheter 23 isguided along the tube toward and in alignment with the pocket 30 by therail system 20, as shown in FIGS. 3 and 4. The rail system 20facilitates the removal and replacement of suction catheters 23 withoutnecessitating the removal of the endotracheal tube 10. The rail system20 is partially defined by the main lumen 12 and the suction catheter 23such that the catheter 23 engages and slidably interlocks withcorresponding railing for moving the catheter 23 along the main lumen12. The rail system 20 comprises a monorail 22 and bi-rail 24. Themonorail traverses the exterior surface of the main lumen 12 andterminates at a predetermined distance above the cuff 14 and pocket 30and preferably in alignment with the top point 42 of the pocket 30. Thebi-rail 24 traverses the suction catheter 23 and slidably engages themonorail. The monorail 22 and bi-rail 24 may comprise integral parts ofthe main lumen 12 and suction catheter 23, respectively.

[0053] With reference to FIG. 4, the monorail 22 comprises a T-stop 26,which is defined by the distal end of the monorail 22. The monorail stop26 prevents the catheter from extending too far into the trachea andcuff pocket 30 to protect the patient from trachea trauma and to preventpuncturing the cuff 14. The stop 26 also insures optimum placement ofthe tip of the suction catheter 23 with respect to the pocket 30. Themonorail stop 26 is smooth and curved and tapers down toward the tube 12to prevent trauma to the patient's trachea during intubation. Themonorail 22 is preferably shaped like a mushroom for slidably engagingthe bi-rail 24 and has a low profile to limit or eliminate the risk oftrachea trauma during intubation. The bi-rail 24 comprises twosubstantially parallel rails that form a corresponding mushroom-likechannel 25 for sliding over the monorail 22. The monorail 22 and bi-railchannel 25 have corresponding cooperative cross-sectional shapes tofacilitate secure, slidable movement of the catheter 23 along themonorail 22 and main lumen 12. The bi-rail channel 25 also provides apocket for inserting a water-based lubricant, such as Surgilube, toreduce friction between the monorail 22 and bi-rail 24 when insertingthe suction catheter 23. The bi-rail 24 also provides additionalrigidity to the suction catheter 23 to facilitate the convenientplacement and traversing of the suction catheter 23 over the main lumen12. The bi-rail 25 and tube 12 provide walls of adherence for hardened,ossified secretions that inevitably develop during long term intubationand create a self-cleaning rail system when changing catheters 23. Whenremoving the suction catheter 23 the hardened secretions are removed.The design of the rail system 20, suction catheter 23 and cuff 14facilitate the application of cleansing and disinfecting rinses toprevent colonization of bacteria around balloon cuff 14 and tracheasurfaces to reduce the risk of infections. The instant invention 10 alsoallows the application of antimocrobial or viscous Lidocaine rinses withno risk of aspiration when aspirating secretions and fluids from thecuff 14. The suction catheter 23 employed is preferably adaptable foruse with a Lopez valve or comparable 3-way stopcocks for NGT/Dobbhofftubes and allows for the administration of oral antimocrobial or viscousLidocaine, chlorhexidine, gluconate and/or lido rinses via the suctioncatheter 23.

[0054] The monorail 22 and bi-rail 24 comprise unobtrusive, modestridges designed to avoid snagging or causing trauma to the inner liningof throat during patient intubation. The monorail 22 and bi-rail 24 haverounded edges so they are unobtrusive. The rounded edges are smooth andcontinuous to reduce or prevent the incident of trauma to the innerlining of the patient's throat during intubation. The rounded edges ofthe monorail 22 have a convex mushroom design as noted above and thebi-rails 24 have corresponding mating contours that facilitate slidableengagement and disengagement between the monorail and bi-rail. Theconvex mushroom design also facilitates the easier removal of residueand hardened secretion build-ups.

[0055] In an alternative embodiment, the tube 10 may have strips 97connected to the pocket 30 and main lumen 12, as shown in FIG. 3. Thestrips 97 control the height and opening of the pocket 30.

[0056] To use the instant invention, a patient is intubated with theendotacheal tube. The tube may be fitted with the suction catheter atthe time of intubation or thereafter. To mount the suction catheter onthe tube, the bi-rail is aligned with and slidably inserted over themonorail so that the bi-rail wraps around the monorail. The suctioncatheter is urged down the tube until the bi-rail engages the monorailstop. When fully inserted, the suction catheter extends beyond the stopand into the cuff pocket. The same procedure is followed to insert asuction catheter while the patient is intubated. The suction cathetermay be replaced without removing the endotracheal tube by sliding thesuction catheter off the monorail and out of the patient's mouth andinserting a new catheter over the monorail as discussed. Once installed,an external vacuum source is used to aspirate secretions through thesuction catheter.

[0057] In one or more alternative embodiments, the instant invention 10may comprise a suction catheter having one or more probes 28 disposed inthe wall of the catheter 23 with or without a sensing tip 29 exposed.The probe 28 may comprise a temperature probe for monitoring a patient'stemperature. The probe 28 may also comprise a oropharyngeal measurementsystem for early warning detection signals for tissue hypoperfusion,which may require an exposed tip 29. In another alternative embodiment,the endotracheal tube body 12 may comprise said probe(s) 28 in the wallas described above with respect to the catheter 23. In anotheralternative embodiment, the cuff balloon 14, and/or tube 12 surfaces maybe impregnated, comprise or be coated with an anti-microbial solutionfor preventing the colonization of bacteria. In another alternativeembodiment, the cuff pocket 30 and, or catheter 23, preferably proximalthe tip, may comprise a radio-opaque material, such as in the form ofplastic to facilitate viewing and gauging the tube 12, cuff pocket 30and/or catheter 23 during use.

[0058] Although the invention 10 is primarily described as a flexibleendotracheal tube, it may also comprise a rigid trachea tube having thesame characteristics and attributes without departing from the scope andspirit of the instant invention as shown in FIG. 11. With reference toFIG. 11, the trachea tube 100 includes the rail system 22-25 and cuffballoon 14 having a tapered pocket 30, as described with reference tothe endotracheal tube 10, but includes a trachea plate 101 having anaperture 102 for receiving and passing the suction catheter 23.

[0059] The instant invention has been shown and described herein in whatis considered to be the most practical and preferred embodiment. It isrecognized, however, that departures may be made therefrom within thescope of the invention and that obvious modifications will occur to aperson skilled in the art.

What is claimed is:
 1. A tracheal secretion evacuation tube for removingpooled secretions from a patient's trachea area, said evacuation tubecomprising: a hollow tube having a wall defining a central passage alongits longitudinal axis, said tube having a distal end and a proximal endwherein the distal end is inserted into the trachea area; an inflatablecuff concentrically disposed on said tube proximal said distal end, saidcuff having a top end, a bottom end and a cuff volume, said cuffcomprising a tapered pocket that resides over a portion of the tube;inflation means for facilitating the selective inflation and deflationof said cuff; and means for guiding a suction catheter along said tubeand at least proximal said pocket.
 2. An evacuation tube as recited inclaim 1, further comprising: a suction catheter adapted for engagingsaid suction catheter to said guiding means so as to facilitate theguidance of said catheter along said tube toward said cuff.
 3. Anevacuation tube as recited in claim 2, wherein said guiding meanscomprises: a first track disposed along at least a portion of said tubeabove said cuff; and a second track disposed along at least a portion ofsaid catheter, said first track and said second track being adapted forslidably interlocking to facilitate the guidance of said catheter alongsaid tube.
 4. An evacuation tube as recited in claim 3, wherein saidcuff comprises: a tapered pocket at least proximal said top end.
 5. Anevacuation tube as recited in claim 1, wherein said cuff comprises: atapered pocket at least proximal said top end.